Global Regulatory CMC Lead (Biotech)

Location: Norwood, Massachusetts, United States; 70% in-office work under a 70/30 model. Only U.S. persons are eligible due to export control requirements.

Salary: $142,500–$256,500 per year, with potential bonus, incentive compensation, or equity.

Company

hirify.global is a biotechnology company building an mRNA technology platform and developing medicines.

What you will do

• Develop and implement CMC regulatory strategies for global IND, CTA, BLA, and MAA submissions.
• Coordinate regulatory CMC activities across product lifecycles and identify regulatory risks.
• Guide product, manufacturing, quality, process development, and analytical development teams.
• Review submission documents for readiness and alignment with health authority guidelines.
• Lead CMC discussions with health authorities and support submission review and approval.
• Assess manufacturing change controls and maintain CMC submission processes and templates.

Requirements

• BS, MS, or PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or a related field.
• 8+ years of experience in the pharmaceutical or biotechnology industry, with manufacturing or analytical experience.
• 5+ years of experience in biologics-focused Regulatory CMC.
• Strong knowledge of global CMC regulations and CTD submission format and content.
• Broad experience with CMC regulatory procedures for drug development, registration, line extensions, and license maintenance.
• Ability to collaborate in a cross-functional matrix environment, work independently, and communicate exceptionally well.

Culture & Benefits

• In-person collaboration model focused on innovation, teamwork, and direct mentorship.
• Healthcare coverage and voluntary benefit programs.
• Fitness, mindfulness, and mental health resources.
• Family planning support, including fertility, adoption, and surrogacy benefits.
• Paid vacation, volunteer days, sabbatical, global recharge days, and year-end shutdown.
• Savings and investment programs, plus location-specific benefits.